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IRCT20231224060516N1 IRCT 2024-01-23 Shiraz University of Medical Sciences Effect of traditional preparation rectal suppository in treatment of hemorrhoids Effect of a traditional preparation rectal suppository from Commiphora mukul (Hook. Ex Stocks) Engl. And Allium porrum L. on hemorrhoids in comparison with conventional anti-hemorrhoid suppository: A double-blind controlled trial 2024-01-20 anticipated 80 Complete https://irct.ir/trial/74727 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are divided into two groups of 40 people randomly by simple block randomization method. All subjects are made aware of the content of the study and written informed consent was obtained from each patient. Coding and sealing of both suppositories by a non-researcher of the study is done by simple block randomization method and using Random Number Generation software. During that time the doctor, researcher and patients are not aware of the block numbers. Common anti-hemorrhoid suppositories are removed from the relevant company's packaging and placed in specially designed boxes for clinical trials, and the labels are removed. The Colo-Rectal Evaluation of Clinical Therapeutics Scale questionnaire (CORECTS) questionnaire completed by individuals. The Interventional group is taking a Traditional Rectal suppository and the control group Anti-hemorrhoid suppository. Both groups of people receive the Drugs in the form of sealed envelopes with a allocation concealment method, and it should be noted that the color and packaging of the both groups drugs are completely similar. The medication in all two groups is taking a rectal suppository for two weeks, twice a day. After the end of the consumption period, the patient's symptoms are evaluated by the questionnaire. The data are collected after 14 days, and then the codes of the drug packages and related questionnaires are opened, Blinding description: The doctor and the patient are blinded in the study. The researcher provides the traditional rectal suppository and conventional anti-hemorrhoid suppository to the patient in sealed envelopes with a allocation concealment method, and the color and packaging of the both groups are completely similar. N/A Hemorrhoid. Intervention 1: The intervention group: 28 rectal suppositories containing Commiphora mukul (Hook. Ex Stocks) Engl. and Allium porrum L. made by the researcher, BID for two weeks. Intervention 2: The control group: 28 conventional anti hemorrhoid suppositories containing hydrocortisone acetate, lidocaine, aluminum sub acetate and zinc oxide, BID for two weeks. Yes - There is a plan to make this available What will be shared: Only a part of data like primary outcome can be shared. When: The access period starts 1 year after the publication time of results To whom: This data will be available only to researchers working in academic and scientific institutions. Conditions: The data will be made available to researchers for further studies or more advanced analysis. Where to obtain: Researchers can send an email regarding the request for the data of our study to Dr. Abdolali Mohagheghzadeh. Email: mohaghegh@sums.ac.ir How to obtain: The researchers can request for this study's data through an e-mail one year after the publication data of this study in one of the pee-reviewed journals. Comments:
public Motahare Nayebzadeh
Karafarin Street, Rokn abad Town
Shiraz Iran (Islamic Republic of) ۷۱۴۶۸۶۴۶۸۵ +98 71 3235 5677 motaharenayeb@sums.ac.ir Faculty of pharmacy scientific Abdolali Mohagheghzadeh
Karafarin Street, Rokn abad Town
Shiraz Iran (Islamic Republic of) ۷۱۴۶۸۶۴۶۸۵ +98 71 3242 4128 mohaghegh@sums.ac.ir Department of Traditional Pharmacy, School of Pharmacy Iran (Islamic Republic of) Suffering from hemorrhoids based on the diagnosis of a general surgeon that does not require emergency surgery The patient must sign a consent form and cooperate during the study Has not been treated for hemorrhoids in the past month no limit no limit Both Fourth-degree hemorrhoids Pregnancy Breastfeeding Diabetes Portal hypertension Various known coagulopathy Liver and kidney failure Inflammatory bowel diseases Perianal fissure Anal fistula Taking medication for hemorrhoids in the last 1 month History Hemorrhoid surgery in the last 6 months Thrombosed external hemorrhoid Strangulated internal hemorrhoid Anal abscess History of perianal surgery Mucosal prolapse Cancer and other malignancies K64 Hemorrhoids and perianal venous thrombosis Treatment - Drugs Treatment - Drugs The intervention group: 28 rectal suppositories containing Commiphora mukul (Hook. Ex Stocks) Engl. and Allium porrum L. made by the researcher, BID for two weeks The control group: 28 conventional anti hemorrhoid suppositories containing hydrocortisone acetate, lidocaine, aluminum sub acetate and zinc oxide, BID for two weeks Pain. Timepoint: Before intervention, 2 weeks after initiation of intervention. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale questionnaire (CORECTS). Itching. Timepoint: Before intervention, 2 weeks after initiation of intervention. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale questionnaire (CORECTS). Swelling. Timepoint: Before intervention, 2 weeks after initiation of intervention. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale questionnaire (CORECTS). Bleeding. Timepoint: Before intervention, 2 weeks after initiation of intervention. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale questionnaire (CORECTS). Shiraz University of Medical Sciences Approved 2023-12-08 Ethics committee of Shiraz University of Medical Sciences Central Building of Medical Sciences, Zand Street. Shiraz Fars Iran (Islamic Republic of)